(25 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for treating various medical conditions of the spine, such as degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion, which are all conditions that require medical therapy. It functions as an adjunct to fusion to provide immobilization of spinal segments.
No
This device is a spinal fixation system, intended for surgical implantation to provide stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly lists physical components like screws, set screws, rods, crosslink, Hook, and connectors, made of Titanium and CoCrMo alloys. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a Spinal Fixation System, which is a collection of implants (screws, rods, etc.) made of metal alloys. These are surgically implanted into the body to stabilize the spine.
- Intended Use: The intended use clearly states that the device is for spinal fixation and fusion, acting as an adjunct to surgical procedures. It does not involve the analysis of biological specimens.
The description focuses on the physical components, materials, sizes, and the anatomical locations and conditions for which the device is intended to be used within the body. This is characteristic of a surgical implant or medical device, not an IVD.
N/A
Intended Use / Indications for Use
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
The Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the attainment of a solid fusion.
In addition, the Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Product codes
NKB, KWP, KWQ
Device Description
This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured using Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 10.0mm diameters with lengths from 20 to 150mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal fixation systems (T1-S2/ilium), anterolateral fixation system (T8-L5), L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The additional size and components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the OpenLoc-L Spinal Fixation System as described in the worst case justification reports. Therefore, we substitute mechanical test data of additional components of OpenLoc-L Spinal Fixation System with the one of the unmodified device (K171813).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 11, 2018
L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, #202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA
Re: K183168
Trade/Device Name: OpenLoc-L Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: November 15, 2018 Received: November 16, 2018
Dear Ms. Seo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183168
Device Name OpenLoc-L Spinal Fixation System
Indications for Use (Describe)
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
-
degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
-
spondylolisthesis;
-
trauma (i.e., fracture or dislocation);
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
-
tumor;
-
stenosis, and
-
failed previous fusion (pseudoarthrosis)
The Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the attainment of a solid fusion.
In addition, the Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
- Submitter: L&K BIOMED Co., Ltd. 1. #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone. +82-2-6717-1983 e-mail: kate.seo@lnkbiomed.com Contact Person: Jihyeon Seo Date prepared: November 15th, 2018
Device Identification 2.
| Trade Name | OpenLoc-L Spinal Fixation System |
|---|---|
| Common Name | Spinal Fixation Appliances |
| Product Code | NKB, KWP, KWQ |
| Regulatory Class | Class II |
| Classification Name | Thoracolumbosacral pedicle screw system |
| 21 CFR 888.3070 |
Purpose of 510(k) 3.
The L&K BIOMED Co. Ltd., hereby submits this Special 510(k): device modification to request a modification to our previous OpenLoc-L Spinal Fixation System. The modifications are to add new component, to change some of the part numbers, to change some of the anodizing colors of screws and to change size of crosslinks. We believe these modifications are eligible for the Special 510(k) process since they have the same fundamental scientific technology and intended use as the predicate device.
4. Predicate or legally marketed devices which are substantially equivalent
- OpenLoc-L Spinal Fixation System K171813
Description of the Device 5.
This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured using Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 10.0mm diameters with lengths from 20 to 150mm.
4
ASTM F136
| Product | Material | Standard |
|---|---|---|
| Screw | Ti-6Al-4V ELI | ASTM F136 |
| Rod | Cobalt-28Chromium-6Molybdenum- | |
| 4Vanadium ELI | ASTM F1537 | |
| Hook | Ti-6Al-4V ELI | ASTM F136 |
| Set Screw | Ti-6Al-4V ELI | ASTM F136 |
Any implant components other than the rods are not manufactured from cobalt chrome.
Indication for Use 6.
Accessories
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/illum), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation);
Ti-6Al-4V ELI
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
- stenosis, and
- failed previous fusion (pseudoarthrosis)
The Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative
5
spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Comparison of the technological characteristics of the subject and the 7. predicate device
| Applicant | L&K BIOMED Co.,Ltd. | L&K BIOMED Co.,Ltd. |
|---|---|---|
| Device | ||
| Name | OpenLoc-L Spinal Fixation System | OpenLoc-L Spinal Fixation System |
| Subject Device | Predicate Device | |
| 510K No. | K171813 | |
| Regulation | ||
| No. | 888.3070 | 888.3070 |
| Product | ||
| Code | NKB, KWP, KWQ | NKB, KWP, KWQ |
| Class | Class II | Class II |
| Material | Titanium alloy (ASTM F136) | |
| CoCr Alloy (ASTM F1537) | Titanium alloy (ASTM F136) | |
| CoCr Alloy (ASTM F1537) | ||
| Sterile | Non-sterile | Non-sterile |
| Rod | Dia: 5.0/5.5/6.0mm Length:40~600mm | Dia: 5.0/5.5/6.0mm Length:40~600mm |
| Screw | Dia:4.0~10.0mm Length:20-150mm | Dia:4.0~8.5mm Length:20-150mm |
| Hooks | Ramped Hook - 6.0 Rod(Narrow, | |
| Standard, Wide) | ||
| General Hook - 6.0 Rod(Narrow, | ||
| Standard, Wide) | ||
| Pedicle Hook - 6.0 Rod(Narrow, | ||
| Standard, Wide) | ||
| Angled Hook - 6.0 Rod(Right, Left) | ||
| Offset Hook - 6.0 Rod(Right, Left) | Ramped Hook - 6.0 Rod(Narrow, Standard, | |
| Wide) | ||
| General Hook - 6.0 Rod(Narrow, Standard, | ||
| Wide) | ||
| Pedicle Hook - 6.0 Rod(Narrow, Standard, | ||
| Wide) | ||
| Angled Hook - 6.0 Rod(Right, Left) | ||
| Offset Hook - 6.0 Rod(Right, Left) | ||
| Indication | ||
| for use | Spinal Fixation System is non-cervical | |
| spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: | ||
| • degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); | ||
| • spondylolisthesis; | ||
| • trauma (i.e., fracture or dislocation); | ||
| • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); | OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: | |
| • degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); | ||
| • spondylolisthesis; | ||
| • trauma (i.e., fracture or dislocation); | ||
| • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); | ||
| tumor; stenosis, and failed previous fusion (pseudoarthrosis) The Spinal Fixation System is a pedicle | ||
| screw system indicated for the treatment | ||
| of severe Spondylolisthesis (Grade 3 | ||
| and 4) of the L5-S1 vertebra in skeletally | ||
| mature patients receiving fusion by | ||
| autogenous bone graft having implants | ||
| attached to the lumbar and sacral spine | ||
| (L3 to sacrum) with removal of the | ||
| implants after the attainment of a solid | ||
| fusion. | ||
| In addition, the Spinal Fixation System | ||
| is intended to provide immobilization | ||
| and stabilization of spinal segments in | ||
| skeletally mature patients as an adjunct | ||
| to fusion in the treatment of the following | ||
| acute and chronic instabilities or | ||
| deformities of the thoracic, lumbar and | ||
| sacral spine: degenerative | ||
| spondylolisthesis with objective | ||
| evidence of neurological impairment, | ||
| fracture, dislocation, scoliosis, kyphosis, | ||
| spinal tumor and failed previous fusion | ||
| (pseudoarthrosis). | stenosis; and failed previous fusion (pseudoarthrosis). The OpenLoc-L Spinal Fixation System is a | |
| pedicle screw system indicated for the | ||
| treatment of severe spondylolisthesis | ||
| (Grades 3 and 4) of the L5-S1 vertebra in | ||
| skeletally mature patients receiving fusion | ||
| by autogenous bone graft having | ||
| implants attached to the lumbar and sacral | ||
| spine (L3 to sacrum) with removal of the | ||
| implants after the attainment of a | ||
| solid fusion. | ||
| In addition, the OpenLoc-L Spinal Fixation | ||
| System is intended to provide | ||
| immobilization and stabilization of spinal | ||
| segments in skeletally mature patients as | ||
| an adjunct to fusion in the treatment of the | ||
| following acute and chronic | ||
| instabilities or deformities of the thoracic, | ||
| lumbar and sacral spine: degenerative | ||
| spondylolisthesis with objective evidence | ||
| of neurological impairment, fracture, | ||
| dislocation, scoliosis, kyphosis, spinal | ||
| tumor, and failed previous fusion | ||
| (pseudoarthrosis) |
6
Performance Testing 8.
The additional size and components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the OpenLoc-L Spinal Fixation System as described in the worst case justification reports. Therefore, we substitute mechanical test data of additional components of OpenLoc-L Spinal Fixation System with the one of the unmodified device (K171813).
9. Conclusion
The OpenLoc-L Spinal Fixation System is substantially equivalent to the device referenced above and is therefore as safe and effective as the predicate devices for its intended use.